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Senior COMOS Analyst and CSV Professional

Location Lengnau, 瑞士 Job Id R-01278470 Job Type 兼职 Category 运营 Remote 全面驻场
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards、 Office

Job Description

About Thermo Fisher Scientific

As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, outstanding customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and relevant impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.

Job Description

  • Act as the administrator of our plant engineering software COMOS. As part of this function you will:
    • provide level 1 and 2 support for all users and perform user management.
    • act as a coordinator between the vendor Siemens and COMOS key users for all topics related to COMOS.
    • handle change controls for COMOS and take ownershiptake responsibility in implementing and validating these changes.
    • write and review lifecycle documents for COMOS, ensuring they meet our especially high standards.
  • Act as validation responsible for all electronic laboratory systems used in the QC department.
    This includes the creation and review of validation documents such as risk assessments, validation plans, and reports, as well as ensuring the validated status of the systems.
  • Act as GMP delegate for the Execution Systems team to check, monitor, and report the status of change control records.
  • Deputize for the Manager CSV Lengnau.

Your qualification

  • Bachelor’s or Master’s degree in engineering or life sciences.
  • Experience in the pharmaceutical industry.
  • Experience as a COMOS administrator or similar role.
  • Strong background in CSV (Computer System Validation) and GMP (Good Manufacturing Practices).
  • Ability to resolve best course of action for system validation and support.
  • Outstanding skills in crafting and reviewing technical documentation.
  • Ambitious and able to strictly adhere to internal and health authority validation and quality standards.
  • Excellent communication and collaboration skills to work seamlessly with complementary teams.
  • Proficiency in English. German is a plus.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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